CADD Legacy Plus 6500 User manual

i
Rate is in
ml/hr
CADD-Legacy®PLUS
Ambulatory Infusion Pump
Model 6500
This Operator’s Manual is for Clinician use
only. Read the entire Operator’s Manual
before operating the pump.
CONTINUOUS OR
INTERMITTENT DELIVERY
Legacy
Operator’s Manual
PLUS
This online version differs from the printed version.
Certain information that is not intended for patients
has been removed.

ii
is manual pertains only to the CADD-Legacy®PLUS Model 6500
ambulatory infusion pump. ere are other CADD-Legacy®pump models
available; review the rear label of the pump to ensure it is a CADD-Legacy®
PLUS Model 6500 pump before programming. is pump delivers medica-
tion at a continuous rate or intermittent rate in milliliters per hour (ml/hr).
is manual is intended for clinician use only. Do not permit patients
to have access to this manual. e pump has 3 security levels designed
to limit patient access. Do not disclose the pump’s security codes or any
other information that would allow inappropriate access to program-
ming and operating functions.
e issue date of this Operator’s Manual is included on the back cover for
the clinician’s information. In the event one year has elapsed between the
issue date and product use, the clinician should contact Smiths Medical
MD, Inc. to see if a later revision of this manual is available.
Technical Assistance
If you have comments or questions concerning the operation of the
CADD-Legacy®pump, please call the appropriate number given below.
When calling, please specify your pump’s soware module. is infor-
mation is located on the start-up screen.
Our sta at Smiths Medical MD, Inc. is available to help clinicians
24 hours a day with the programming and operation of the CADD-
Legacy®infusion system.
U.S. Distribution European Representative
Smiths Medical MD, Inc. Smiths Medical International Ltd.
1265 Grey Fox Road WD24 4LG UK
St. Paul, MN 55112 USA [phone]
1 800.426.2448 (USA)
+1 651.633.2556

iii
Read this entire Operator’s Manual before operating the CADD-Legacy®
ambulatory infusion pump.
Failure to properly follow warnings, cautions, and instructions could
result in death or serious injury to the patient.
Warnings
•is Operator’s Manual should be used by clinicians only. Do not
permit patients to have access to this manual, as the information
contained would allow the patient complete access to all program-
ming and operating functions. Improper programming could result
in death or serious injury to the patient.
•To avoid explosion hazard, do not use the pump in the presence of
ammable anesthetics or explosive gases.
•For those patients who are likely to be adversely aected by unintend-
ed operations and failures, including interrupted medication or uid
delivery from the device, close supervision and provision for immedi-
ate corrective action should be provided.
•If the pump is used to deliver life-sustaining medication, a backup
pump should be available.
•e pump should not to be used for delivery of blood or cellular blood
products.
•If the pump is dropped or hit, inspect the pump for damage. Do not
use a pump that is damaged or is not functioning properly. Contact
Smiths Medical MD, Inc. Customer Service to return a pump for
service.
•Use of a syringe with the CADD™Administration Set may result in
UNDER-DELIVERY of medication. Syringe function can be adversely
aected by variations in plunger dimension and lubricity, which can
result in greater force required to move the syringe plunger. A syringe
plunger will lose lubrication as it ages and, as a result, the amount of
under-delivery will increase which could on occasion, be signicant.
erefore, the type of medication and delivery accuracy required
must be considered when using a syringe with the CADD®pump.

iv
Clinicians must regularly compare the volume remaining in the sy-
ringe to the pump’s displayed values such as RES VOL and GIVEN in
order to determine whether under-delivery of medication is occurring
and if necessary, take appropriate action.
•System delivery inaccuracies may occur as a result of back pressure or
uid resistance, which depends upon medication viscosity, catheter
size, and extension set tubing (for example, microbore tubing).
•Do not administer medications to the epidural space or subarachnoid
space unless the medication is indicated for administration to those
spaces.
•To prevent the infusion of medications that are not indicated for
epidural space or subarachnoid space infusion, do not use administra-
tion sets that incorporate injection sites.
•If a Medication Cassette Reservoir, CADD™Extension Set or CADD™
Administration Set is used for medication delivery into the epidural
or subarachnoid space, clearly dierentiate them from those used for
other routes of infusion, for example, by color coding, or other means
of identication.
•When the Air Detector is turned o, the pump will not detect air in
the uid path. Periodically inspect the uid path and remove any air
to prevent air embolism.
•Follow the Instructions for Use provided with the Medication Cas-
sette Reservoir and CADD™Extension Set, or CADD™Administra-
tion Set, paying particular attention to all warnings and cautions
associated with their use.
•When the Upstream Occlusion Sensor is turned o, the pump will not
detect occlusions upstream (between pump and uid container). Periodi-
cally inspect the uid container for decreasing volume, inspect the uid
path for kinks, a closed clamp, or other upstream occlusions. Upstream
occlusions could result in under- or non-delivery of medications.
•Do not disclose to the patient the pump’s security codes or any other
information that would allow the patient complete access to all pro-
gramming and operating functions.

v
•Do not use rechargeable NiCad or nickel metal hydride (NiMH) bat-
teries. Do not use carbon zinc (“heavy duty”) batteries. ey do not
provide sucient power for the pump to operate properly.
•Always have new batteries available for replacement. If power is lost,
non-delivery of medication will occur.
•If the pump is dropped or hit, the battery door or tabs may break. Do
not use the pump if the battery door or tabs are damaged because the
batteries will not be properly secured; this may result in loss of power
and non-delivery of medication.
•If a gap is present anywhere between the battery door and the pump
housing, the door is not properly latched. If the battery door becomes
detached or loose, the batteries will not be properly secured; this
could result in loss of power and non-delivery of medication.
•Ensure that the ± 6% System Delivery Accuracy specication is taken
into account when programming the pump and/or lling the Medica-
tion Cassette Reservoir. Failure to do so may result in medication in
the reservoir becoming depleted sooner than expected.
•is pump delivers medication at a continuous rate or intermittent
rate in milliliters per hour (ml/hr). Programming the pump at a
delivery rate other than what is prescribed will cause over or under
delivery of medication.
•Close the uid path tubing with the clamp before removing the cas-
sette from the pump to prevent unregulated gravity infusion.
•For detailed instructions and warnings pertaining to the Medication
Cassette Reservoir or CADD™Administration Set, please refer to the
instructions for use supplied with the product for preparing the prod-
uct for use.
•Attach the cassette (the part of the Medication Cassette Reservoir or
CADD™Administration Set that attaches to the pump) properly. An
improperly attached or detached cassette could result in unregulated
gravity infusion of medication from the uid container or a reux of
blood.

vi
If you are using a CADD™Administration Set or Medication Cassette
Reservoir that does not have the ow stop feature (catalog number
does not start with 21-73xx): You must use a CADD™Extension Set
with an integral Anti-Siphon Valve or a CADD™Administration
Set with either an integral or Add On Anti-Siphon Valve to protect
against unregulated gravity infusion that can result from an improp-
erly attached cassette.
•Do not prime the uid path with the tubing connected to a patient as
this could result in overdelivery of medication or air embolism.
•Ensure that the entire uid path is free of all air bubbles before con-
necting to the patient to prevent air embolism.
•Prior to starting infusion, inspect the uid path for kinks, a closed
clamp, or other upstream occlusions, and remove any air to prevent
air embolism.
•e use of Power Supplies other than those listed in the Electromag-
netic emissions declaration may result in increased emissions or
decreased immunity of the Pump.
•e Pump should not be used adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the user should verify normal opera-
tion of the pump in the conguration in which it is to be used.
•ere are potential health hazards associated with improper disposal of
batteries, electronics, and contaminated (used) reservoirs and extension
sets. Dispose of used batteries, reservoirs, extension sets and other used
accessories, or a pump that has reached the end of its useful life, in an envi-
ronmentally safe manner, and according to any regulations that may apply.
Cautions
•Do not operate the pump at temperatures below +2°C (36°F) or above
40°C (104°F).
•Do not store the pump at temperatures below -20°C (-4°F) or above
60°C (140°F). Do not store the pump with the Medication Cassette
Reservoir or CADD™Administration Set attached. Use the Protective
Cassette provided.

vii
•Do not expose the pump to humidity levels below 20% or above 90%
relative humidity.
•Do not store the pump for prolonged periods of time with the batter-
ies installed.
•Frozen medication must be thawed at room temperature only. Do not
heat the Medication Cassette Reservoir in a microwave oven as this
may damage the medication, the Medication Cassette Reservoir, or
cause leakage.
•Do not immerse the pump in cleaning uid or water or allow solution
to soak into the pump, accumulate on the keypad, or enter the battery
compartment.
•Do not clean the pump with acetone, other plastic solvents, or abra-
sive cleaners, as damage to the pump may occur.
•Do not expose the pump to therapeutic levels of ionizing radiation
as permanent damage to the pump’s electronic circuitry may occur.
e best procedure to follow is to remove the pump from the patient
during therapeutic radiation sessions. If the pump must remain in the
vicinity during a therapy session, it should be shielded, and its ability
to function properly should be conrmed following treatment.
•Do not expose the pump directly to ultrasound, as permanent dam-
age to the pump’s electronic circuitry may occur.
•Do not use the pump in the vicinity of magnetic resonance imaging
(MRI) equipment as magnetic elds may adversely aect the operation
of the pump. Remove the pump from the patient during MRI proce-
dures and keep it at a safe distance from magnetic energy.
•Do not use the pump near ECG equipment as the pump may interfere
with the operation of the equipment. Monitor ECG equipment care-
fully when using this pump.
•Do not sterilize the pump.
•Use only Smiths Medical MD, Inc. accessories as using other brands
may adversely aect the operation of the pump.

viii
•CADD-Legacy®pumps are sealed units. A broken or damaged seal
will, therefore, be considered conclusive evidence that the pump has
been misused and/or altered, which voids any and all warranties. All
service and repair of CADD-Legacy®pumps must be performed by
Smiths Medical MD, Inc. or its authorized agents.
•Check appropriate medication stability for time and temperature to
assure stability with actual pump delivery conditions.
•Information regarding the recommended Medication Cassette Reser-
voirs, CADD™Extension Sets, CADD™Administration Sets and ac-
cessories is available in the Product List that accompanies the CADD-
Legacy® pump.

ix
Table of Contents
Warnings iii
Cautions vi
1.0 General Description 1
Introduction........................................................................................................1
Indications...........................................................................................................1
Epidural/Subarachnoid Administration.........................................................1
Symbols................................................................................................................3
Pump Diagram...................................................................................................4
Description of the Keys, Display, and Features .............................................5
e Main Screen.................................................................................................8
Lock Levels..........................................................................................................9
Security Codes....................................................................................................9
Lock Level Table...............................................................................................10
2.0 Pump Setup and Programming 11
Installing or Replacing the Batteries .............................................................11
Watching Power Up .........................................................................................16
Changing to Lock Level 0 (LL0) ....................................................................17
Programming the Pump: General Instructions ..........................................18
Delivery Methods.............................................................................................19
Programming Screens for Continuous Delivery ........................................21
Programming Continuous Delivery ............................................................23
Programming Screens for Intermittent Delivery .......................................25
Programming Intermittent Delivery.............................................................29
Removing a Cassette........................................................................................32
Attaching a Cassette ........................................................................................33
Priming the Tubing (Using the Pump) and Connecting to the Patient...35
Inserting the Tubing into the Air Detector..................................................37
Setting the Lock Level for the Patient ...........................................................39
CDM: Programming with Upper Limits, Adjusting Rate
in Lock Level 1 ............................................................................................. 40
IDM: Stopping the Pump During the Dose .................................................41

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3.0 Operating the Pump 43
Starting the Pump........................................................................................... 43
Stopping the Pump ......................................................................................... 43
Turning the Pump On/O............................................................................. 44
Resetting the Reservoir Volume.................................................................... 44
4.0 Biomed Functions 45
Overview: Accessing the Biomed Functions............................................... 45
Air Detector On/O ....................................................................................... 46
Upstream Sensor On/O ................................................................................47
Changing the Delivery Method .................................................................... 48
5.0 Reference 49
Messages and Alarms, Alphabetical List ......................................................49
Cleaning the Pump and Accessories.............................................................53
Exposure to Radiation, Ultrasound, Magnetic Resonance Imaging
(MRI), or Use near ECG Equipment .........................................................55
Technical Description..................................................................................... 56
Specications (Nominal).............................................................................57
Accuracy Test Results ..................................................................................62
Electromagnetic Emissions and Immunity Declarations...................... 64
Safety Features and Fault Detection ......................................................... 68
Soware Safety Features..............................................................................70
Data Handling Soware Safety Features ..................................................71
Annual Functional Inspection and Testing Procedures.........................72
Inspection Procedures .................................................................................72
Testing Procedures .......................................................................................73
Occlusion Pressure Range Tests .................................................................78
Accuracy Tests ..............................................................................................81
Index ................................................................................................................. 86
Limited Warranty ........................................................................................... 88

1
General
Description
Section 1: General Description
1.0 General Description
Introduction
e CADD-Legacy®PLUS ambulatory infusion pump provides mea-
sured medication therapy to patients in hospital or outpatient settings.
erapy should always be overseen by a physician or a certied, licensed
healthcare professional. As appropriate to the situation, the patient
should be instructed in using and troubleshooting the pump.
Indications
e CADD-Legacy®PLUS pump is indicated for intravenous, intra-ar-
terial, subcutaneous, intraperitoneal, epidural space, or subarachnoid
space infusion. e pump is intended for therapies that require a con-
tinuous or intermittent rate of infusion.
Epidural/Subarachnoid Administration
e selected medication must be used in accordance with the indications
included in the package insert accompanying the medication. Admin-
istration of any medication by this pump is limited by any warnings,
precautions, or contraindications in the medication labeling.
Analgesics
Administration of analgesics to the epidural space is limited to use with
indwelling catheters specically indicated for either short-or long-term
medication delivery.
Administration of analgesics to the subarachnoid space is limited to use
with indwelling catheters specically indicated for short-term medica-
tion delivery.
Anesthetics
Administration of anesthetics to the epidural space is limited to use with
indwelling catheters specically indicated for short-term medication
delivery.

2
General
Description
Section 1: General Description
WARNING:
• Do not administer medications to the epidural space or subarach-
noid space unless the medication is indicated for administration to
those spaces. Medications not intended for epidural or subarach-
noid space infusion could result in death or serious injury to the
patient.
• To prevent the infusion of medications that are not indicated for
epidural space or subarachnoid space infusion, do not use admin-
istration sets that incorporate injection sites. e inadvertent use
of injection sites for infusion of such medications could result in
death or serious injury to the patient.
• If a Medication Cassette Reservoir, CADD™Extension Set or
CADD™Administration Set is used for medication delivery into
the epidural or subarachnoid space, clearly dierentiate them from
those used for other routes of infusion, for example, by color cod-
ing, or other means of identication. Medications not intended for
epidural or subarachnoid space infusion could result in death or
serious injury to the patient.

3
General
Description
Section 1: General Description
Symbols
Direct Current (Power Jack)
OAccessory Jack
fAttention, see Instructions for Use
KClass II Equipment
Type CF Equipment
ESplashproof - water splashed against pump housing will have no
harmful eects (see Cleaning the Pump and Accessories, Section
5, for additional important information)
DDate of Manufacture
<Catalog (reorder) number
>Serial Number
ZCollect Separately
@Authorized Representative in the European CommunityAuthorized Representative in the European Community

4
General
Description
Section 1: General Description
Pump Diagram
Display
Power Jack
Accessory Jack
AC Indicator
Light
Air Detector
Keypad
Cassette
Front
View
Threaded
Mounting Hole
Battery
Compartment
Cassette Lock
Power Jack
symbol
Accessory
Jack symbol
®
Rear
View

5
General
Description
Section 1: General Description
Description of the Keys, Display, and Features
AC Indicator Light
e green indicator light is on when you are using the AC adapter to
power pump.
Display
e Liquid Crystal Display (LCD) shows programming information and
messages. In this manual, the term “display” is synonymous with display
panel or LCD.
Keypad
e keys on the keypad are described below. A key beeps when pressed if
it is operable in the current lock level.
⁄
used to start and stop pump delivery, and silence alarms.
¤
used to enter (save) a new value in the pump’s memory when
programming pump settings or to clear values from record-keep-
ing screens. It is also used to return from the Biomed Functions
to the main screen (Section 4).
‹
used to ll the tubing and to remove air bubbles from the uid
path.
Œ
used to view or change the pump’s current lock level. Lock levels
are used to limit patient access to certain programming and op-
erating functions. (See Lock Levels, this section.)
„
used to move from one programming screen to the next without
changing the setting or value displayed; silences alarms.
´
used to “scroll up” or increase a value, or scroll through Biomed
Function settings.
Î
used to “scroll down” or decrease a value, or scroll through
Biomed Function settings.

6
General
Description
Section 1: General Description
Å
used to put the pump into a low power state when not in use or
back into full power.
Power Jack
You may plug an AC Adapter into the Power jack as an alternate source
of power. e indicator light on the front of the pump will illuminate
when the AC Adapter is in use.
Accessory Jack
is jack is used for accessory cables. See the Instructions for Use supplied
with those accessories.
Air Detector
e Air Detector is on the pump in the area shown in the diagram. If air
is detected in the part of the tubing that passes through the Air Detec-
tor, an alarm sounds and delivery stops. (See Section 5 for Air Detector
specications.) If an Air Detector is not required, it may be turned o.
(See Section 4, Biomed Functions.)
WARNING: When the Air Detector is turned o, the pump will not
detect air in the uid path. Periodically inspect the uid path and
remove any air to prevent air embolism. Air embolism could result in
death or serious injury to the patient.
Cassette
e cassette is the portion of the CADD™Medication Cassette Reservoir
or CADD™Administration Set that attaches to the bottom of the pump.
e following single-use products are compatible with the CADD-Legacy®
pump:
•CADD™ Medication Cassette Reservoir (50 or 100 ml), used with the
CADD™Extension Set
•CADD™Administration Set

7
General
Description
Section 1: General Description
WARNING: Follow the Instructions for Use provided with the Medi-
cation Cassette Reservoir and CADD™Extension Set, or the CADD™
Administration Set, paying particular attention to all warnings and
cautions associated with their use. Incorrect preparation and/or use of
these products could result in serious patient injury or death.
Threaded Mounting Hole
e optional Polemount Bracket Adapter attaches to the threaded mounting
hole in the back of the pump, allowing you to hang the pump on an IV pole.
Battery Compartment
Two AA batteries t into the battery compartment. e AA batteries serve as
the primary source of power, or as a backup when an AC Adapter is in use.
Cassette Lock
is attaches the cassette (the part of the Medication Cassette Reservoir
or CADD™Administration Set that attaches to the pump) to the pump.
is allows you to secure the cassette to the pump. If the cassette be-
comes unlocked while the pump is running, delivery will stop and an
alarm will occur. If the cassette becomes unlocked while the pump is
stopped, an alarm will occur.
Other Features Not Shown
Upstream Occlusion Sensor: e pump contains an upstream occlu-
sion sensor. is feature may be turned on or o. (See Section 4, Biomed
Functions.) When the sensor is turned on, and an upstream occlusion
(between pump and uid container) is detected, an alarm will sound,
delivery will stop, and the display will show “Upstream Occlusion.”
WARNING: When the Upstream Occlusion Sensor is turned o, the
pump will not detect occlusions upstream (between pump and uid
container). Periodically inspect the uid container for decreasing
volume, inspect the uid path for kinks, a closed clamp, or other up-
stream occlusions. Upstream occlusions could result in under- or non-
delivery of medications. If undetected, these occlusions could result in
death or serious injury to the patient.

8
General
Description
Section 1: General Description
Downstream Occlusion Sensor: e pump contains a downstream oc-
clusion sensor. When a downstream occlusion (between the pump and
patient access site) is detected, an alarm will sound, delivery will stop,
and the display will show “High Pressure.”
Reservoir Volume Alarm: e Reservoir Volume alarm indicates when
the uid in the uid container is low or depleted. Each time you change
the uid container, you may reset the Reservoir Volume to the originally
programmed volume. en, as medication is delivered, the Reservoir
Volume automatically decreases. When the pump calculates that 5 ml
remain in the uid container, beeps sound and “ResVol Low” appears on
the main screen. is alarm recurs at every subsequent decrease of 1 ml
until the Reservoir Volume reaches 0 ml, at which point the pump stops
and the Reservoir Volume empty alarm sounds.
The Main Screen
e main screen is the starting point for programming or viewing the
pump’s settings.
If no keys are pressed for a period of time (2 minutes), the display reverts
to the main screen. When the two AA batteries are low, “LowBat”
appears on the main screen.
When running:
Status of pump
Reservoir
Volume
Battery Status
Status of
Reservoir
Volume
RUN LowBat
ResVol 50.0ml
When stopped:
Status of pump
STOPPED

9
General
Description
Section 1: General Description
Lock Levels
Lock levels are used to limit patient access to certain programming and
operating functions. e table on the next page lists the functions that
are accessible in Lock Level 0 (LL0), Lock Level 1 (LL1), and Lock Level 2
(LL2). When a function is accessible, the key associated with the function
beeps when pressed. If a function is not accessible, the pump ignores the
key press and a beep does not sound. Section 2, Pump Setup and Pro-
gramming, describes how to change the lock level.
Security Codes
e following security codes are preset by the manufacturer for the
clinician’s use:
** Text Omitted from Online Version **
WARNING: Do not disclose to the patient the pump’s security
codes or any other information that would allow the patient com-
plete access to all programming and operating functions. Improper
programming could result in death or serious injury to the patient.

10
General
Description
Section 1: General Description
Lock Level Table
is table lists the operations that are accessible in each lock level while
the pump is stopped and running. LL0 permits complete access to all
programming and operating functions. LL1 permits limited control of
pump programming and operations. LL2 permits only minimal control
of pump operations.
*Continuous Delivery Mode = CDM; Intermittent Delivery Mode = IDM
Pump Operations
and Programming
Stopped Running
LL0 LL1 LL2 Any Lock
Level
Stop/Start the pump Yes Yes Yes Yes
Reset Reservoir Volume Yes Yes Yes No
Prime Yes Yes No No
Change the Lock Level Yes, w/
code
Yes, w/
code
Yes, w/
code No
Change Continuous Rate
(CDM)* Yes Up to LL0 value No No
Clear Given amount
(CDM & IDM)* Yes Yes No No
Change Dose Volume (IDM)* Yes No No No
Change Dose Duration (IDM)* Yes No No No
Change Dose Cycle (IDM)* Yes No No No
Change KVO Rate (IDM)* Yes No No No
Change Dose Starts in Delay
(IDM)* Yes Yes No No
Biomed Functions
Access to Functions Yes, w/
code No No No
Air Detector On/O Yes, w/
code View Only View Only View Only
Upstream Occlusion Sensor
On/O
Yes, w/
code View Only View Only View Only
Changing the Delivery Mode Yes, w/
code View Only View Only View Only